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Long-term Effects of Non-invasive Ventilation in Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Patients

This study has been terminated.
(Lack of budget)
Sponsor:
Information provided by (Responsible Party):
FluidDA nv
ClinicalTrials.gov Identifier:
NCT01592656
First received: May 3, 2012
Last updated: January 15, 2014
Last verified: October 2012

May 3, 2012
January 15, 2014
February 2011
October 2013   (final data collection date for primary outcome measure)
Changes in the distribution of the mass flow per lobe and the relative proportion of bloodvessels, as obtained from functional respiratory imaging (FRI) and arterial blood gas (ABG). [ Time Frame: At baseline, after 1 month and after 6 months of treatment with non-invasive ventilation (NIV) ] [ Designated as safety issue: No ]
The primary objective of this study is the comparison of the mass flow distribution and redistribution versus the relative blood flow per lobe (as a surrogate for V/Q matching) with FRI and ABG values in hypercapnic COPD patients treated with long-term NIV.
Changes in the distribution of the mass flow per lobe and the relative proportion of bloodvessels, as obtained from functional imaging (FI) and arterial blood gas (ABG). [ Time Frame: At baseline, after 1 month and after 6 months of treatment with non-invasive ventilation (NIV) ] [ Designated as safety issue: No ]
The primary objective of this study is the comparison of the mass flow distribution and redistribution versus the relative blood flow per lobe (as a surrogate for V/Q matching) with FI and ABG values in hypercapnic COPD patients treated with long-term NIV.
Complete list of historical versions of study NCT01592656 on ClinicalTrials.gov Archive Site
  • Health related quality of life [ Time Frame: At baseline, after 1 month and after 6 months ] [ Designated as safety issue: No ]
    Saint George's Respiratory Questionnaire (SGRQ) and Severe Respiratory Insufficiency (SRI) Questionnaire
  • Lung function tests [ Time Frame: At baseline, after 1 month and after 6 months ] [ Designated as safety issue: No ]
    Spirometry, reversibility, plethysmography, diffusion, Maximal Inspiratory Pressure (MIP), Maximal Expiratory Pressure (MEP)
  • Hospital admissions [ Time Frame: After 1 month and after 6 months ] [ Designated as safety issue: No ]
    Length and frequency of admission, severity of exacerbations, ICU admissions
  • Exercise tolerance [ Time Frame: At baseline, after 1 month and after 6 months ] [ Designated as safety issue: No ]
    6 minutes walking test and oximetry measurement
  • Local airway volume and resistance [ Time Frame: At baseline, after 1 month and after 6 months ] [ Designated as safety issue: No ]
    CT-scan of thorax. CT scan is performed with a low radiation protocol. These images are made to perform computational fluid dynamics on in order to obtain more information on regional lung function characteristics.
  • Prediction of breathing pattern [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    The tertiary objective of the study is to predict the breathing pattern (including tidal volume) during NIV when using the data of patient specific lobar compliance and regional resistance at baseline.
  • Health related quality of life [ Time Frame: At baseline, after 1 month, after 6 months and after 12 months ] [ Designated as safety issue: No ]
    Saint George's Respiratory Questionnaire (SGRQ), VAS dyspnea, questionnaire UZA BiPAP, Severe Respiratory Insufficiency (SRI) Questionnaire
  • Lung function tests [ Time Frame: At baseline, after 1 month, after 6 months and after 12 months ] [ Designated as safety issue: No ]
    Spirometry, reversibility, plethysmography, diffusion, MIP, MEP
  • Hospital admissions [ Time Frame: After 1 month, after 6 months and after 12 months ] [ Designated as safety issue: No ]
    Length and frequency of admission, severity of exacerbations, ICU admissions
  • Exercise tolerance [ Time Frame: At baseline, after 1 month, after 6 months and after 12 months ] [ Designated as safety issue: No ]
    6 minutes walking test and oximetry measurement
  • Local airway volume and resistance [ Time Frame: At baseline, after 1 month and after 6 months ] [ Designated as safety issue: No ]
    CT-scan of thorax. CT scan is performed with a low radiation protocol. These images are made to perform computational fluid dynamics on in order to obtain more information on regional lung function characteristics.
  • Prediction of breathing pattern [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    The tertiary objective of the study is to predict the breathing pattern (including tidal volume) during NIV when using the data of patient specific lobar compliance and regional resistance at baseline.
Not Provided
Not Provided
 
Long-term Effects of Non-invasive Ventilation in Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Patients
Long-term Effects of Non-invasive Ventilation in Hypercapnic COPD Patients.

In this multicenter study the comparison of the mass flow distribution and redistribution versus the relative blood flow per lobe (as a surrogate for Ventilation/ Perfusion (V/Q) matching) with functional respiratory imaging (FRI) and arterial blood gas (ABG) values will be evaluated in hypercapnic Chronic Obstructive Pulmonary Disease (COPD) patients. Therefore a low dose Computed Tomography (CT) scan will be taken in a population of 30 patients with non-invasive ventilation (NIV) and in a control group of 10 patients without NIV. The CT-scan will be used for FRI.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Radiation: Functional Respiratory Imaging
    CT-scan of thorax. At baseline, after 1 month and after 6 months.
  • Other: Lung compliance measurement
    At baseline
  • Device: Non-invasive ventilation (Respironics)
    Long-term non-invasive ventilation, starting at baseline until 6 months. At baseline the patients should have persisting hypercapnia (pCO2 > 45 mmHg) under optimal conservative treatment other than NIV. The patients can be hospitalised or being treated at home at inclusion.
    Other Name: Trilogy device (Respironics)
  • Active Comparator: Non-invasive ventilation (NIV)
    30 patients will receive NIV during 6 months = group 1
    Interventions:
    • Radiation: Functional Respiratory Imaging
    • Other: Lung compliance measurement
    • Device: Non-invasive ventilation (Respironics)
  • Placebo Comparator: Control group
    10 patients will act as control group, they will not be treated with NIV = group 2
    Interventions:
    • Radiation: Functional Respiratory Imaging
    • Other: Lung compliance measurement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age: ≥ 40 years old
  • Men and women
  • Written informed consent obtained
  • COPD patients GOLD II, III and IV
  • Persisting hypercapnia (pCO2 > 45 mmHg ) notwithstanding adequate treatment modalities (including oxygen) as proposed by the GOLD guidelines
  • Stopped smoking
  • Total lung capacity (TLC) > 85%

Exclusion Criteria:

  • Treatment with home NIV or Continuous Positive Airway Pressure (CPAP)
  • Asthma
  • Restrictive lung disease
  • Symptomatic or uncontrolled heart failure
  • Current malignancy
  • Suspected bad compliance for NIV treatment
  • Pregnant women
  • Not be able to speak the language of the participating center
  • Received an investigational product within 4 weeks prior to inclusion in the study
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Netherlands
 
NCT01592656
FLUI-2010-68
No
FluidDA nv
FluidDA nv
Not Provided
Principal Investigator: Wilfried De Backer, MD, PhD University Hospital, Antwerp
Principal Investigator: Peter Wijkstra, MD, PhD University Medical Centre Groningen
FluidDA nv
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP